Assessment of knowledge, practices, and barriers to pharmacovigilance among nurses at a teaching hospital, Ghana: a cross‑sectional study

Pharmacovigilance (PV) is the science and activities relating to identifying, understanding, assessing, and preventing risks associated with drugs. One of the most effective ways of monitoring the effective use of drugs in a population is spontaneous adverse drug reporting (SADR) [1]. No drug is harmless and free from adverse effects. There are two major effects of every drug: therapeutic and adverse effects. Anyone using drugs can experience some form of adverse reaction (ADR) [2]. Conducting a pharmacovigilance assessment is one of the most effective ways of monitoring the adverse effects of drug use on a population [3]. Pharmaceutical companies usually conduct a clinical trial of drugs to determine the therapeutic and harmful effects before the drugs are made available on the market for use [4].

A clinical trial conducted before drug approval does not show every aspect of related adverse effects of the approved drug. Prolonged use of medication can help detect common ADRs [5]. This calls for continuous monitoring of drugs to report any undocumented ADRs during the clinical trial.

The prevalence of ADRs is increasing globally and has become one of the leading causes of morbidity and mortality in developed countries [6]. ADRs also prolong the hospital admissions of a patient. A prospective study showed that the average number of days spent in hospitals was eight days for patients without ADRs compared to 20 days for patients with ADRs [7].

ADRs are a severe problem in health care delivery, particularly during the management of chronic diseases. ADRs are a primary reason for therapy change and drug withdrawal from the market and affect adherence to treatment regimens by patients and treatment protocols by prescribers [8].

Ghana became the 65th nation to join the WHO Programme for International Drug monitoring and started her pharmacovigilance and spontaneous ADR monitoring activities in 2001 [9]. Documentation of ADRs by health professionals is a major challenge of the program, where health professionals usually underreport cases of ADRs [10]. The WHO recommended a reporting rate of 200 cases per million population per year. A study conducted in Ghana found that for a standard of 100 cases per million people, a reporting rate of 23 was expected. However, only 1.55 was observed, despite the widespread availability of ADR forms in health facilities across the country [11].

Several studies conducted across the globe on pharmacovigilance have cited various reasons for underreporting of ADRs. While some studies reported unawareness of the reporting procedure, others reported ignorance of the reporting procedure as the common reason given by most health professionals [10, 12‐15]. Since nurses spend more time with the patient on the ward and are likely to see patients developing ADRs, evaluating nurses' knowledge, practices, and barriers to pharmacovigilance and adverse drug reaction reporting can aid in the development of initiatives for enhancing reporting schemes to promote patient safety.

The study was conducted to generally assess the knowledge, practices, and barriers to pharmacovigilance among nurses at a teaching hospital. Findings from this study showed that the majority (71.2%) of nurses did not have adequate knowledge of pharmacovigilance and their reporting system. It was evident that out of the 125 nurses, 64.8% had not seen the form for reporting ADRs. Less than half (41.6%) of the respondents had in-service training on drug safety and reporting ADRs, yet (75.2%) did not know the information that is required on the ADR form. Various educational platforms for healthcare professionals, such as pharmacovigilance training and workshops, are critical for increasing nurses’ knowledge, practices, and barriers concerning ADRs [19]. There was no statistically significant relationship between attending in-service training and reporting ADRs. Even though almost 42% of the respondents had some form of training on pharmacovigilance, their knowledge regarding pharmacovigilance was poor. The poor knowledge of pharmacovigilance could be attributed to the priority that this group of medical professionals place on the problem of ADRs, which is not promising. Additionally, another reason could be that the nurses who participated in the in-service training did not pay prompt attention during the training or that there were not sufficient learning materials because it is expected that those who attended the in-service training should know the required information on the ADR form. Since most of the nurses do not know the procedure for reporting ADRs, it will be difficult for them to report any adverse drug events. In contrast, in a study conducted in India, healthcare workers who received educational training on ADR reporting had a proper understanding of pharmacovigilance and better awareness of ADRs [20]. Healthcare workers should receive appropriate education and training regularly to improve their understanding of ADR reporting. Other research found that educational interventions improved ADR reporting awareness [21]. A study in Nepal showed that educational intervention might improve awareness of ADR reporting because many healthcare professionals have experienced ADR throughout their clinical practice but lacked adequate understanding of where and how to report ADR. Ongoing efforts are necessary to raise awareness of ADR reporting through the provision of education and training programs at regular intervals [22].

Findings from the study show that the nurses (84.8%) had good knowledge of the purpose of pharmacovigilance. This finding is supported by a study conducted in Karachi, Pakistan, where physicians had good knowledge of ADRs, but only 15.5 and 16% of them understood where and how to report ADRs, with only 7.5% of those surveyed having access to the ADR system [23]. Another study conducted in the Volta Regional Hospital of Ghana found that doctors, pharmacists, and nurse prescribers are knowledgeable about pharmacovigilance in Ghana [24].

Among the nurses interviewed, 47.2% indicated having nursed patients with an adverse drug reaction. When asked whether they reported the ADRs by filling out an ADR report form, 47.46% stated they did not report it. Findings from the current study on reporting ADRs are higher than the 42.5% found in the study carried out in Northern Nigeria [13], 41% found in medical practitioners in India [25], and 21% found among doctors in the Greater Accra Region of Ghana [10].

The most prevalent explanation for not reporting ADRs was that 28.5% of the nurses were unaware that they were required to report. Additionally, 28.5% did not know the reporting procedure, whereas 25% regarded the ADR as typical and usually linked with that drug. The results from the current study are similar to those conducted in Ibadan, Nigeria, among doctors, where unawareness of the presence of the ADR form and ignorance of the reporting procedure prevented reporting among doctors [12]. Another study conducted in Karachi, Pakistan, among physicians also reported that approximately 20% of the respondents considered that reporting a single ADR makes no significant contribution to the ADR reporting system, whereas 48% thought that ADR reporting generates extra work [23].

According to research conducted in Barcelona, a lack of time to report an ADR, the absence of an ADR reporting system in hospitals, and a lack of knowledge of the spontaneous reporting system were the primary causes of underreporting ADRs in Spain [26].

When the nurses were asked what would discourage them from reporting ADRs, the most common reasons stated were lack of time and heavy workload (20.0%), unawareness of the reporting procedure (20.08%), concern that the report may be wrong (16.0%), and unavailability of reporting from the hospitals (15.2%). Similar results have been observed in other studies. A study conducted among physicians in Ghana found that the biggest barrier to ADR reporting was a lack of time and a heavy workload. However, in that study, respondents reported a "lack of confidence in the reporting system" as a barrier to ADR reporting more frequently than "unavailability of the reporting form" [10].

Another study conducted in the United Arab Emirates also reported not knowing how to report, nonremuneration for reporting and lack of time to actively look for ADRs discouraged doctors from reporting ADRs [14].

Nurses in this study had insufficient knowledge of pharmacovigilance and its reporting procedure but had good knowledge of the purpose of reporting ADR. Even though there was no statistical association between attending in-service training and practice of pharmacovigilance, hospitals should pay much attention to the in-service training of nurses, given the crucial role that nurses play in pharmacovigilance activities and adverse drug reaction reporting. Additionally, making the ADR reporting form more accessible, allowing for online submission of ADR reports, integrating electronic reporting, and giving encouragement and feedback can all help to improve ADR reporting performance in the long term.